Effect of Music Therapy on Anxiety of Caregivers of Alzheimer's Disease Patients

Sponsor
Association de Musicothérapie Applications et Recherches Cliniques (Other)
Overall Status
Completed
CT.gov ID
NCT05317910
Collaborator
(none)
26
1
1
3.6
7.2

Study Details

Study Description

Brief Summary

This clinical trial evaluates the impact of music interventions on caregivers of patients with memory disorders, Alzheimer's disease, dementia and related disorders. This study will follow caregivers of patients within the rehabilitation day care hospital "Memory and Frailty" (Hôpital de Jour de Réadaptation Mémoire et Fragilités), Sainte-Marie Paris Hospital.

Condition or Disease Intervention/Treatment Phase
  • Other: MUSIC CARE
N/A

Detailed Description

This clinical trial evaluates the impact of music on caregivers of patients with memory disorders, Alzheimer's disease, dementia and related disorders. This study will follow caregivers of patients within the rehabilitation day hospital "Memory and Frailty " (Hôpital de Jour de Réadaptation Mémoire et Fragilités), Sainte-Marie Paris Hospital.

All participants will benefit from a first session of a relaxation-type musical technique in the Day care Hospital (HDJ), they will then follow the sessions in their own homes. During the first visit, all participants will complete self-assessments, including a questionnaire on musical preferences and a self-assessment anxiety scale.

The expected inclusion period is 30 days. Carers will be equipped with tablets, headphones, eye masks and workbooks/questionnaires to use every day for one month in their homes. A relaxation-type receptive musical technique is used. The standardized 20-minute musical sequence is broken down into several phases that gradually lead the patient to a state of relaxation using the new U technique. The effect works by reducing the musical rhythm, orchestral formation, frequencies and volume (the "U" descending phase). After a maximum relaxation phase (lower part of the "U"), a re-activating phase (ascending branch of the "U") follows. All the musical sequences, built with the U-shape editing method, were specially produced by the music publishing company Music Care©. During the first session in HDJ, the subjects will lie on a relaxation table with a raised headrest (extended or semi-seated listening position) in an enclosed space, calm, secure and comfortable, with minimum lighting, so that the participant feels comfortable. The music will be played on headphones.

The main objective is to reduce anxiety among carers who accompany patients with memory disorders, Alzheimer's disease and related dementia.

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Effect of Music Therapy on Anxiety of Carers of Alzheimer's Disease Patients
Actual Study Start Date :
Apr 1, 2022
Actual Primary Completion Date :
Jul 20, 2022
Actual Study Completion Date :
Jul 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Music intervention

Music intervention (duration 20 minutes) every day for 30 days

Other: MUSIC CARE
Relaxation-type receptive musical intervention technique. The standardized 20-minute musical sequence is broken down into several phases that gradually lead the patient to relaxation using the new U-Mount technique [1, 2] (Figure 1). The effect works by reducing the musical rhythm, orchestral formation, frequencies and volume (the "U" descending phase). After a maximum relaxation phase (lower part of the "U"), a re-activating phase (ascending branch of the "U") is followed.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline STAI score at 28 days [Day 1 and Day 28]

    Long-term anxiety will be measured using the State Trait Anxiety Inventory (STAI) scale. The STAI is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Scores range from 20 to 80, with higher scores correlating with greater anxiety.

Secondary Outcome Measures

  1. Change on EVA score immediately after each session [Before and immediately after each session (up to 28 days (one session every day))]

    Short-term anxiety will be evaluated by a Visual Analogue Scale (VAS) with a score from 0 to 10, which assesses caregiver anxiety, with higher scores correlating with greater anxiety.

  2. Change from baseline STAI score at 15 days [Day 1 and Day 15]

    Long-term anxiety will be measured using the State Trait Anxiety Inventory (STAI) scale. The STAI is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Scores range from 20 to 80, with higher scores correlating with greater anxiety.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Anxiety Self-Assessment Score (STAI) greater than 46 at Day 1

  • Patient relationship (child, spouse, brother/sister)

Exclusion Criteria:
  • Presence of a psychiatric disorder

  • Intellectual disability

  • Major hearing loss

  • Professional musician

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sainte-Marie Hospital Paris France 75014

Sponsors and Collaborators

  • Association de Musicothérapie Applications et Recherches Cliniques

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Association de Musicothérapie Applications et Recherches Cliniques
ClinicalTrials.gov Identifier:
NCT05317910
Other Study ID Numbers:
  • AIDALZ
First Posted:
Apr 8, 2022
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Association de Musicothérapie Applications et Recherches Cliniques
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2022